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Non-enzymatic lactate sensor system for intensive care applications

Country of Origin: Germany
Reference Number: TODE20190617001
Publication Date: 17 June 2019

Summary

Continuous measurement of lactate during emergency or intensive care is very important as it is a critical parameter to lactate acidosis and the mortality rate. A group within a German research institute, specialised in bio-electro-mechanical systems and sensors therefore seeks partners to develop a new lactate potentiometry based sensing approach that would eliminate the problems from currently used enzymes. Envisaged partnerships are a research or technical co-operation or a license agreement.

Description

A German research institute is involved in application-oriented research at the interface between  life sciences and material science. An interdisciplinary team of scientists is developing new technologies for companies and public research sponsors in the areas of pharma and biotechnology, biomedical technology, and surface and materials technology. 

In the bio-electro-mechanical systems & sensors group, electrochemical sensors for medical and biotechnological applications are developed in close cooperation with research institutes and commercial partners. Unlike the common glass housed liquid junction electrodes, those electrochemical sensors are based on a solid contact principle to allow for miniaturizing, measurements under harsh conditions as well as applications like medical implants. In the latter case such sensors have additionally to fulfill legal requirements relating to their material composition to prevent patients from harm. A similar situation is given in the field of bio fermentation and environmental testing. Neither shall sensor material components contaminate the sample nor should the sensor surface itself be affected by deposition of blocking layers, so called biofouling. To ensure biocompatibility on the one hand and to prevent the failure of such sensors a new class of fluorinated sensor materials needs to be established. 

In an ongoing research project the institute and partners recently have shown that acetate sensors based on such innovative materials like fluorinated ionophores, ionic sites and membranes are possible. Other combinations led to an increased sensitivity for lactate without the need for enzymes. In various stress situations, lactate is a critical parameter related to so called lactate acidosis (ICD-10 definition E 87.2), e.g. under conditions like a septic shock (serum lactate levels above C=2mmol/l). In 2017, 37348 cases of azidosis-related diseases were registered in Germany alone, 1171 people died from them. The serum lactate value is also a very predictive parameter in emergency or intensive care, for levels above C=10mmol/l a mortality rate of 80% can be expected, if this condition lasts more than 48h a 100% mortality is given. Several studies demand for a regular measurement of lactate continuously during intensive care. In Germany 1942 Clinical facilities exist, 1160 thereof with intensive care units (ICU) and further 404 with Intensive care department with 2.13 million treatment cases; for EU a total number of 2,068,892 acute care and 73,585 critical care beds is estimated. 

In principle two ways of lactate level measurements in acute care situations are conceivable: subcutaneously and by blood testing: while measurements in catheters is preferred due to the fact, that separate measurement e.g. via a subcutaneous approach includes the risk of additional sources of infects, albeit subcutaneous measurements show a higher data-quality and open room for applications beyond the scope of acute care. Therefore the institute envisions a lactate micro sensor platform for both – catheter based measurements and short term implant solutions. 



The institute seeks on the one hand a partnership with industry partners, willing to accompany a research project from the perspective of medical certification issues, the commercial use case and subsequently deriving a product development in case of success. 

On the other hand research questions are to be addressed which should additionally include researchers from the field of intensive care and surgery specialists to allow for studies of medical aspects, handling and the effectiveness of such a sensor system. They prefer furthermore a scenario, where the project is led by a specific industry partner to ensure the strategy matches with business demands early on. Possible partnerships are a research or technical co-operation including a subsequent license agreement.

Advantages and Innovations

State of the art lactate measurement means the use of enzyme (LOD Lactate Oxidase, LDH Lactate Dehydrogenase) coated amperometric sensors, widely applied in sports applications.

An enzyme free, potentiometry based sensing approach would instead provide the following advantages:

- no enzyme deposition nor critical immobilization processes are needed; 

- no electron transfer is included (direct potential measurement);

- no cofactors or mediators involved; 

- the expected shelf lifetime > compared to enzyme based biosensors  (between 3...150 days, depending on many factors such as immobilisation process of enzymes, storage conditions etc)

- common sterilization methods (steam, Gamma, ethylene oxide) applied to enzyme based biosensors lead to denaturation of macromolecules and more or less defunctionalize these sensors.

- use of fluorinated sensor materials to prevent biofouling and to allow for biocompatibility



First results of modified fluorinated sensor materials show a clear sensitivity and selectivity for lactate, see additional information/pictures.

Stage Of Development

Concept stage

Requested partner

Type of partner sought:

industry partners, academy/ research organisation



Specific area of activity of the partner 

Manufacturer: 

- medical devices/applications, leading the project, giving input to the following aspects: market perspectives, prototyping/read out units, subsequent product needs, including design, lifetime, sensing parameters;

- special chemicals/polymer synthesis; develop and providing special chemicals, such as fluorinated polymers and Ionophors, Ionic Sites,  

- electrochemical sensors, for view on subsequent production, therefor support with process development and scaling of batch prototyping



User: 

- Implant surgery, Intensive Care, Bioreactors, support with knowledge from the medical perspective relating to surgery, test scenarios, handling and Medical devices approval procedure (FDA, MDR, IVDR…)



Research organisation: 

- calculations of polymer chemicals



Tasks to be performed by the types of partner sought:  

 

To develop a lactate sensor system for medical applications partners from several fields of activity are needed:

- Catheter manufacturer, willing to include additional features like sensors and realizing a subsequent 

  commercial distribution;

- Medical equipment manufacturer (hardware/software/packaging) to combine the sensor/catheter unit to a readout Hardware, including the integration into a clinical data management system;

- Intensive care physicians to accompany the whole process from layout to test under conditions of use;

- Specialists for medical certification issues (EU-wide, FDA?);

- A company with experience in development and synthesis of special chemicals (fluorinated) for use as sensor materials, such as Ionophores, Ionic sites, polymers; 

- A sensor manufacturer for developing under the focus of scalable production processes;